For the U Sample Clauses

For the U. S. The strategy for the commercial launch of the Product in the U.S. shall be described in a comprehensive plan that describes the pre-launch, launch and subsequent Commercialization activities and budget for the Product (including, if available, advertising, education, planning, marketing, sales force training and allocation, distribution, pricing, and reimbursement) (the "U.S. Commercialization Plan"). The JSC shall establish appropriate subcommittee(s) at least thirty-six (36) months prior to the then-current date of expected Regulatory Approval for such Product in the U.S. in the Field as determined in accordance with then-current U.S. Development Plan (such date, the "U.S. Approval Date"). The JSC and its subcommittees shall develop and approve an initial U.S. Commercialization Plan at least twenty-four (24) months prior to the U.S. Approval Date. The initial U.S. Commercialization Plan and subsequent revisions thereto, which revisions shall be approved by the JSC from time to time, shall contain such information as the JSC believes necessary for the successful commercial launch of such Product in the U.S. in the Field in each of the Initial Indications and shall generally conform to the level of detail utilized by the Parties in preparation of their own product commercialization plans. The U.S. Commercialization Plan shall be deemed Confidential Information of both Parties, and each Party shall use such U.S. Commercialization Plan only to the extent necessary to carry out its Commercialization activities for the Product. From time to time as reasonably necessary during the term of Commercialization of a Product in the U.S., the JSC shall update the U.S. Commercialization Plan (it being understood that Affymax shall be responsible for generating draft updates relating to the Renal Indications and Takeda shall be responsible for generating draft updates relating to the Oncology Indications, for review and approval by the JSC).
Sample 1Sample 2
For the U. S. BI will provide Micromet with an initial overview of estimated Commercialization activities in the U.S., containing such information as reasonably necessary for Micromet to evaluate whether to opt out of its co-promotion right pursuant to Section 4.5.2 (including, by way of example, information regarding the target markets, anticipated detailing efforts and allocations, etc.), at least [***] ( [***] ) [***] prior to the then-current date of expected Marketing Approval for a Product in the U.S. After Micromet has indicated to BI that it does not want to opt-out of the co-promotion in U.S. according to Section 4.5.2, the Parties will enter into good faith negotiations on the Co-Promotion Agreement drafted by BI according to Section 4.5.1. After execution of the Co-Promotion Agreement BI will provide a more detailed U.S. Commercialization Plan, which will be further discussed by the JCPT and approved by the JSC sufficiently prior to the U.S. Approval Date. Such detailed U.S. Commercialization Plan will contain such information as the JSC believes necessary for the successful commercial launch of such Product in the U.S. in the Field in each of the applicable indications and will generally conform to the level of detail utilized by the Parties in preparation of their own product commercialization plans. The U.S. Commercialization Plan will be deemed Confidential Information of both Parties, and each Party will use such U.S. Commercialization Plan only to the extent necessary to carry out its Commercialization activities for the Product. From time to time as reasonably necessary, the JSC will update the U.S. Commercialization Plan (it being understood that BI will be primarily responsible for generating such draft updates for review and approval by the JSC).
Sample 1

Related to For the U

  • Compliance with the Sxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply in all material respects with any provision of the Sxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Sxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • Compliance with the Xxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply in all material respects with any provision of the Xxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Xxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • Compliance with Xxxxxxxx-Xxxxx Act The Company will comply with all applicable securities and other laws, rules and regulations, including, without limitation, the Xxxxxxxx-Xxxxx Act, and use its best efforts to cause the Company’s directors and officers, in their capacities as such, to comply with such laws, rules and regulations, including, without limitation, the provisions of the Xxxxxxxx-Xxxxx Act.

  • Credit Reporting; Gramm-Leach-Bliley Act (a) With respect to each Mortgage Loan, each Sexxxxxx xxxxxx xx xully furnish, in accordance with the Fair Credit Reporting Act and its implementing regulations, accurate and complete information (e.g., favorable and unfavorable) on its borrower credit files to Equifax, Experian and TransUnion Credit Information Company (three of the credit repositories), on a monthly basis. (b) Each Servicer shall comply with Title V of the Gramm-Leach-Bliley Act of 1999 and all applicable regulations promulgatxx xxxxxxxxxx, xxxating to the Mortgage Loans required to be serviced by it and the related borrowers and shall provide all required notices thereunder.

  • For purposes of Treas Reg. Section 1.671- 5(f)(1)(iv)(A)(2), the date of the last deposit under 2.01(b) prior to the expiration of the initial offering period, as certified to the Trustee by the Depositor, shall be considered the 'start-up date' of the Trust.

  • Compliance with Xxxxxxxx-Xxxxx The Company and its subsidiaries and their respective officers and directors are in compliance in all material respects with the applicable provisions of the Xxxxxxxx-Xxxxx Act of 2002 (the “Xxxxxxxx-Xxxxx Act,” which term, as used herein, includes the rules and regulations of the Commission promulgated thereunder).

  • Know-How Necessary for the Business The Intellectual Property Rights are all those necessary for the operation of the Company’s businesses as it is currently conducted or as represented, in writing, to the Purchasers to be conducted. The Company is the owner of all right, title, and interest in and to each of the Intellectual Property Rights, free and clear of all liens, security interests, charges, encumbrances, equities, and other adverse claims, and has the right to use all of the Intellectual Property Rights. To the Company’s knowledge, no employee of the Company has entered into any contract that restricts or limits in any way the scope or type of work in which the employee may be engaged or requires the employee to transfer, assign, or disclose information concerning his work to anyone other than of the Company.

  • Without limiting the other provisions of this Section 3.1, among other delegations by the Trustees, the Trustees have determined that there is a significant risk that the Trust and its shareholders may be adversely affected by investors with short term trading activity and/or whose purchase and redemption activity follows a market timing pattern as defined in the prospectus for the Trust, and have authorized the Trust, the Underwriter and the Trust's transfer agent to adopt procedures and take other action (including, without limitation, rejecting specific purchase orders in whole or in part) as they deem necessary to reduce, discourage, restrict or eliminate such trading and/or market timing activity. You agree that your purchases and redemptions of Portfolio shares are subject to, and that you will assist us in implementing, the Market Timing Trading Policy and Additional Policies (as described in the Trust's prospectus) and the Trust's restrictions on excessive and/or short term trading activity and/or purchase and redemption activity that follows a market timing pattern.

  • Compliance with Usury Laws The mortgage rate (exclusive of any default interest, late charges, Yield Maintenance Charge or Prepayment Premium) of such Mortgage Loan complied as of the date of origination with, or was exempt from, applicable state or federal laws, regulations and other requirements pertaining to usury.

  • Nxxxx X Xxxxxxx is hereby designated as the Chief Executive Officer and Chief Financial Officer and Jxxx Xxxxxxxxx is designated the General Counsel and Secretary of the Company, each to serve in such capacity until his earlier death, resignation or removal from office.